COMMENTARY

Conflicts of Interest and Guidelines: Is Bias a Worry?

Kenneth W. Lin, MD, MPH

Disclosures

July 27, 2015

Editorial Collaboration

Medscape &

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Hi, everyone. I am Dr Kenny Lin. I am a family physician at Georgetown University School of Medicine, and I blog at Common Sense Family Doctor. My topic today is conflicts of interest in practice guidelines and medical education. This issue was recently cast into the limelight by a series of three editorials that were published in the New England Journal of Medicine.[1,2,3] In this series, Lisa Rosenbaum, a staff correspondent and cardiologist at Brigham and Women's Hospital, argued that efforts to decrease financial conflicts of interest in guideline development and medical education have gone too far. As an example, Dr Rosenbaum cited the colleague skepticism about the 2013 American College of Cardiology (ACC) and American Heart Association (AHA) cholesterol guideline,[4] which greatly increased the number of adults who are eligible for statin therapy. Seven out of the 15 members of this guideline panel had received or were receiving research grants or consulting fees from companies that sell statins. However, she pointed out that the systematic review of the evidence was performed by a nonconflicted independent contractor and that panel members with current conflicts of interest were not permitted to vote on the guideline recommendations.

Dr Rosenbaum went on to argue that nonfinancial sources of bias such as past clinical experience or institutional prestige can be as powerful as financial bias in altering decision-making for individual patients or in guideline development. She worried that focusing exclusively on financial conflicts of interest may have serious unintended consequences such as discouraging key experts with such conflicts from serving on guideline panels, discouraging clinicians from taking important guidelines seriously, and eroding public trust in medicine and science.

Before giving my take on this topic, I want to disclose my own conflicts of interest. I have previously made charitable contributions to PharmedOut, a Georgetown University Medical Center project that campaigns against unsavory pharmaceutical marketing practices. I also chair a subcommittee on clinical practice guidelines for the American Academy of Family Physicians that recently evaluated the ACC/AHA cholesterol guideline and decided not to fully endorse it, in part due to the panel members' financial conflicts of interest. I agree that financial conflicts of interest are not the only possible sources of bias. However, I strongly disagree with Dr Rosenbaum that preventing physicians with financial conflicts from developing guidelines or from creating continuing medical education materials will reduce their quality or usefulness. In fact, I believe the opposite to be true. Experts in medical subspecialties are not only more likely to be financially biased but intellectually biased as well. Is it any surprise that radiologists are up in arms about the US Preventive Services Task Force's conclusion that screening mammography in women in their forties should be optional or that urologists are opposed to the Task Force's recommendation against prostate-specific antigen screening in men? As the Task Force has demonstrated over the past three decades and as the Institute of Medicine has affirmed, the primary qualification for membership on a trustworthy guideline panel should be expertise in evidence-based medicine.

Similarly, authors of clinical reviews in medical journals should not have financial conflicts of interest. During my tenure as an editor of American Family Physician, we prohibited review articles from having any financial relationships with companies that have an interest in the topic of the article. Last year, BMJ announced a similar policy for its clinical education articles.[5] Both journals believe that there is a critical difference between an industry-supported clinician authoring a research paper vs interpreting that research for practice by authoring clinical guidelines or reviews. In these cases, simple disclosure does not suffice to prevent bias.

By the way, the Annals of Internal Medicine recently published a synopsis of the cholesterol guideline developed by the US Department of Veterans Affairs (VA) and the US Department of Defense (DoD).[6] They reviewed the same body of evidence that the ACC/AHA guideline writers did. There are large areas of agreement between the 2 guidelines but notable differences, too. Specifically, the VA/DoD guideline suggested higher 10-year cardiovascular risk thresholds for recommending a statin for primary prevention (12% vs 7.5%) and for considering a statin for primary prevention (6% vs 5%). They also preferred moderate-dose to high-dose statins in most clinical situations. Why is the VA/DoD guideline more conservative about statin use? Same evidence, different panel, different conclusions. It's worth noting that none of the VA/DoD panelists had any financial conflicts of interest.

This has been Dr Kenny Lin for Medscape Family Medicine. Thank you for listening.

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